Colorectal CancerPhase 2NCT04258111
IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR)/microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
A Phase 2 study testing IBI310 (anti-CTLA-4 antibody) and Sintilimab(anti-PD-1 antibody) in people with Colorectal Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The main purpose of this study is to assess the efficacy and safety of IBI310 in combination with sintilimab in patients with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) locally advance or metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- IBI310 (anti-CTLA-4 antibody) and Sintilimab(anti-PD-1 antibody)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2020to 26 Oct 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed colorectal adenocarcinoma
- Imaging confirmed locally-advanced or metastatic colorectal cancer
- Measurable disease by CT or MRI
- MSI-H confirmed by central lab
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Who cannot join
- Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Subjects with active,known or suspected autoimmune disease
- Subjects with a history of primary immune deficiency
- Subjects with severe infectious diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Multicenter, Phase 2 Study of IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR) /microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
The main purpose of this study is to assess the efficacy and safety of IBI310 in combination with sintilimab in patients with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) locally advance or metastatic colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- IBI310 (anti-CTLA-4 antibody), Sintilimab(anti-PD-1 antibody)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI310 (anti-CTLA-4 antibody)Biological
Specified dose on specified days
Sintilimab(anti-PD-1 antibody)Biological
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| IBI310 + Sintilimab | Experimental | Not described Receives: Biological: IBI310 (anti-CTLA-4 antibody); Biological: Sintilimab(anti-PD-1 antibody) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate (ORR) in all MSI-H CRC patients as determined by independent review committee
Measured: Up to 3 years
Secondary outcomes (7)
ORR in all MSI-H CRC patients based on investigator assessment.
Measured: Up to 3 years
Progression-Free Survival (PFS) both by investigator and IRC
Measured: Up to 3 years
Disease Control Rate (DCR) both by investigator and IRC
Measured: Up to 3 years
Duration of Response (DoR) both by investigator and IRC
Measured: Up to 3 years
Time To Response (TTR) both by investigator and IRC
Measured: Up to 3 years
Overall Survival
Measured: Up to 3 years
Incidence of adverse events (AE)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start27 Aug 2020
- Primary completion26 Oct 2020
- Study completion26 Oct 2020
Why it stopped: After careful consideration, our company has decided to revise the overall development strategy for IBI310 and discontinue further registration research for this project. Consequently, the ongoing screening process will be terminated, and this decisi
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258111
- Sponsor's protocol ID
- CIBI310D201
- Status last verified
- Sep 2022
- First submitted
- 4 Feb 2020
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase 2 Study of IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR) /microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04258111
- Acronym / sponsor ID
- CIBI310D201
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After careful consideration, our company has decided to revise the overall development strategy for IBI310 and discontinue further registration research for this project. Consequently, the ongoing screening process will be terminated, and this decisi
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 26 Oct 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess the efficacy and safety of IBI310 in combination with sintilimab in patients with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) locally advance or metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI310 + Sintilimab | Experimental | Biological: IBI310 (anti-CTLA-4 antibody), Biological: Sintilimab(anti-PD-1 antibody) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed colorectal adenocarcinoma
- Imaging confirmed locally-advanced or metastatic colorectal cancer
- Measurable disease by CT or MRI
- MSI-H confirmed by central lab
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Key exclusion criteria (4 listed)
- Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Subjects with active,known or suspected autoimmune disease
- Subjects with a history of primary immune deficiency
- Subjects with severe infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI310 (anti-CTLA-4 antibody)Specified dose on specified days | Biological | IBI310 + Sintilimab |
| Sintilimab(anti-PD-1 antibody)Specified dose on specified days | Biological | IBI310 + Sintilimab |
Primary outcome
ORR
Time frame: Up to 3 years
Objective Response Rate (ORR) in all MSI-H CRC patients as determined by independent review committee
7 secondary outcomes
ORR in all MSI-H CRC patients based on investigator assessment.
Time frame: Up to 3 years
Progression-Free Survival (PFS) both by investigator and IRC
Time frame: Up to 3 years
Disease Control Rate (DCR) both by investigator and IRC
Time frame: Up to 3 years
Duration of Response (DoR) both by investigator and IRC
Time frame: Up to 3 years
Time To Response (TTR) both by investigator and IRC
Time frame: Up to 3 years
Overall Survival
Time frame: Up to 3 years
Incidence of adverse events (AE)
Time frame: Up to 3 years
Results and safety
The study was stopped early (reason given: After careful consideration, our company has decided to revise the overall development strategy for IBI310 and discontinue further registration research for this project. Consequently, the ongoing screening process will be terminated, and this decisi). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBI310 (anti-CTLA-4 antibody) and Sintilimab(anti-PD-1 antibody) in people with Colorectal Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: After careful consideration, our company has decided to revise the overall development strategy for IBI310 and discontinue further registration research for this project. Consequently, the ongoing screening process will be terminated, and this decisi). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.